Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Area of Science:

• Clinical Trials Methodology
• Health Data Science
• Research Reporting Standards

Background:

• Randomized controlled trials (RCTs) face challenges in recruitment, cost, and generalizability.
• Emerging RCT designs utilize routinely collected health data (e.g., registries, EHRs), but reporting lacks standardization.
• Existing reporting guidelines need extension to accommodate these novel trial designs.

Purpose of the Study:

• To develop a consensus-driven extension of the Consolidated Standards of Reporting Trials (CONSORT) statement.
• To provide specific reporting guidelines for RCTs conducted using cohorts and routinely collected health data.
• To enhance the transparency and methodological rigor of these increasingly adopted trial designs.

Main Methods:

• A five-phase development process, including a systematic review and Delphi exercise.
• Identification of reporting considerations from existing guidelines (STROBE, RECORD) and literature.
• Expert consensus meeting to finalize checklist items for the new reporting guideline.

Main Results:

• The systematic review will identify key reporting aspects for cohort-based RCTs.
• Delphi exercises and expert consensus will refine a core set of reporting items.
• A finalized checklist and elaboration-explanation document will be produced.

Conclusions:

• The developed CONSORT extension will standardize reporting for RCTs using routinely collected health data.
• Improved reporting will enhance the transparency and interpretability of trial findings.
• This initiative supports the rigorous application and evaluation of innovative clinical trial methodologies.